Selective Treatment of Oral Povorcitinib in Prurigo Nodularis Study 1 (STOP-PN1)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Incyte Corp.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Immune System Diseases [C20]

Trial duration

12 Dec 2024 → ongoing

Decision date (initial)

2024-12-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Incyte Corporation

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the effect of povorcitinib on itch and skin lesions in participants with PN

Secondary objectives 6

1. To evaluate the effect of povorcitinib on itch and skin lesions in participants with PN
2. To further evaluate the effect of povorcitinib on itch in participants with PN
3. To further evaluate the effect of povorcitinib on skin lesions in participants with PN
4. To further evaluate the effect of povorcitinib on itch and skin lesions in participants with PN
5. To evaluate the effect of povorcitinib on QoL
6. To evaluate the safety and tolerability of povorcitinib.

Conditions and MedDRA coding

Prurigo Nodularis

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-003313-PIP03-23

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. 1. Ability to comprehend and willingness to sign a written ICF for the study.
2. 2. 18 to 75 years of age. Note: For South Korea, 19 years of age or older.
3. 3. Clinical diagnosis of PN for at least 3 months before screening.
4. 4. Pruritus, defined as an average Itch NRS score ≥ 7 during the 7 days prior to Day 1.
5. 5. ≥ 20 pruriginous lesions in total on ≥ 2 different body regions (both legs, and/or both arms, and/or trunk) at screening and Day 1.
6. 6. IGA-CPG-S score ≥ 3 at screening and Day 1.
7. 7. Documented history of treatment failure, demonstrated intolerance, or contraindication to a previous PN treatment (eg, TCS or TCI) with the exception of treatment failure with prior topical or systemic JAK or TYK2 inhibitors (see Exclusion Criterion 10).
8. 8. Willingness to avoid pregnancy or fathering children based on the criteria detailed in section 5.1. of the protocol (under inclusion criteria 8).
9. 9. Willing and able to comply with the study protocol and procedures.

Exclusion criteria 21

1. 1. Chronic pruritus due to a condition other than PN.
2. 10. History of treatment failure for PN or any other inflammatory condition.
3. 11. History of clinically significant (per investigator's judgment) drug or alcohol abuse within 6 months prior to screening.
4. 12. Initiation or changing the dose of any of the treatments listed in section 5.2. of the protocol (under exclusion criteria 12) within 3 months of Day 1 or expected dose change of any of the following treatments during the initial 24 weeks of treatment with study drug (ie, during the PC period).
5. 14. Concurrent enrollment in another clinical study.
6. 15. At the screening visit, any of the laboratory abnormalities defined in Table 6 of the protocol.
7. Evidence of infection with Mycobacterium tuberculosis (ie, TB) as defined in Section 8.3.5.2.
8. 16. Active HIV or acquired immunodeficiency syndrome. Active HIV is defined as a confirmed positive anti-HIV antibody test (see Section 8.3.5.3).
9. 17. Evidence of HBV or HCV infection or risk of reactivation (see Section 8.3.5.4).
10. 18. Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib (refer to the IB) and/or other products in the same class.
11. 19. Any condition, laboratory result, or result of screening assessments that would, in the investigator's and sponsor's (or designee's) judgment, interfere with full participation in the study, including administration of study drug and attending required study visits, pose a significant risk to the participant, or interfere with interpretation of study data.
12. 2. Neuropathic and psychogenic pruritus.
13. 20. The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health Code.
14. 3. Diagnosis of PN secondary to medications.
15. 4. Active AD lesions within 3 months of screening.
16. 5. Pregnant (or are considering pregnancy) or breastfeeding.
17. 6. Concurrent conditions or history of other diseases detailed in section 5.2. of the protocol (under exclusion criteria 6).
18. 7. A screening 12-lead ECG that demonstrates clinically significant abnormalities requiring treatment (eg, acute myocardial infarction, serious tachyarrhythmias or bradyarrhythmias) or that is indicative of serious underlying heart disease (eg, cardiomyopathy, major congenital heart disease, low voltage in all leads, Wolff Parkinson-White syndrome) or criteria associated with QT/QTcF abnormalities.
19. 8. Significant trauma or major surgery (per investigator's assessment) within 30 days prior to screening.
20. 9. Planned or expected major surgery during the initial 24 weeks of treatment with study drug (ie, during the PC period of the study).
21. 13. Receipt of medical treatment or investigational drugs within intervals specified in section 5.2 of the protocol (under exclusion criteria 13)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of participants achieving Itch NRS4 (≥ 4-point improvement [reduction] in Itch NRS score from baseline) and IGA-CPG-S-TS (IGA CPG-S score of 0 or 1 with a ≥ 2-grade improvement from baseline) at Week 24

Secondary endpoints 3

1. Proportion of participants achieving Itch NRS4 at Week 24
2. Proportion of participants achieving IGA CPG S-TS at Week 24
3. Proportion of participants achieving Itch NRS4 at Week 4

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Incyte Corp.

Sponsor organisation

Incyte Corp.

Address

1801 Augustine Cut Off

City

Wilmington

Postcode

19803-4404

Country

United States

Scientific contact point

Organisation

Incyte Corp.

Contact name

Clinical Trial Information

Public contact point

Organisation

Incyte Corp.

Contact name

Clinical Trial Information

Third parties 9

Locations

7 EU/EEA countries · 58 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 73 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

14 submissions — initial application plus substantial / non-substantial modifications